Provide continued access to Maraviroc to subjects who have completed previous studies of Maraviroc and continue to receive clinical benefit. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment:

124

Study Start Date:

May 2012

Estimated Study Completion Date:

January 2020

Estimated Primary Completion Date:

January 2020 (Final data collection date for primary outcome measure)

Intervention Details:

Drug: Continued Access Arm

All subjects will be on maraviroc 300 mg twice a day, unless a dose adjustment is required due to certain concomitant medications. For those subjects in South Africa and Argentina who were previously receiving Combivir along with maraviroc in Study A4001026, Combivir will be supplied as tablets containing 150 mg lamivudine and 300 mg zidovudine. One Combivir tablet will be taken orally twice a day.

Eligibility

Ages Eligible for Study:

16 Years and older

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study.

Subject has participated in a clinical trial that evaluated maraviroc and is continuing to derive clinical benefit from maraviroc treatment.

Subject must agree to use an acceptable method of contraception for the duration of the study as outlined at the end of the inclusion criteria.

Subject agrees to the specified study procedures.

Exclusion Criteria:

Subject who is an investigational site staff member or an employee of the Sponsor that is directly involved in the conduct of the trial.

Other severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.

Contra-indications to use of maraviroc as described in the Investigator Brochure.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01776996